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The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMED-4 recording | Device |
| Measure | Description | Time Frame |
|---|---|---|
| IMED-4 recordings | The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present for CRM device follow-up are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Coast Cardiology | Encinitas | California | 92024 | United States | ||
| Desert Heart |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Palm Springs |
| California |
| 92262 |
| United States |